Sunday, February 2, 2014

Reps on Safety Issues, or, the Sounds of Silence

When writing in HOOKED about drug reps, I asserted that they seem to soft-pedal safety concerns, seldom mentioning any adverse reactions to their drugs. Unfortunately, the data at the time were restricted to one major study in France, so one could claim that we actually knew very little about what reps did or did not say to physicians on this subject.

We can therefore welcome the more recent study of Dr. Barbara Mintzes and her colleagues (subscription required), who studied drug rep-physician interactions in four cities in three countries, Montreal, Vancouver, Sacramento, and Toulouse. A major weakness immediately arises as they relied on physician recall of the visit rather than directly observing the visit. However, it's nearly impossible to imagine drug reps agreeing to have these visits observed, or acting "normal" if they knew the visit was being recorded, so I gather this is the best evidence that is ever likely to be available. The folks ended up with 255 physicians reporting on 1692 detail visits.

Essentially, this study confirmed the earlier French study. They used as a primary outcome "minimally adequate safety information," which they defined as "mention of [at least] 1 approved indication, [at least one serious adverse event (SAE), [at least] 1 common non-serious adverse event (AE), [at least] 1 contraindication (CI) and no unapproved indications or unqualified safety claims". They thought they were setting the bar pretty low with these requirements, so it's impressive that this desired endpoint was reached overall in only 1.7% of all visits, ranging from 0.9% in Sacramento to 3.0% in Toulouse.

As an example of just how far off the mark was the information provided in most details, in terms of safety, the physicians recorded what they took to be the "key message" of the detail. For details for Avandia, taken off the market in Europe and restricted in Canada and the U.S. in 2010 due to concerns about excessive heart risks, key messages included, "'Avandia is safe even in patients with heart disease, as long as they don't have heart failure' (Montreal); 'Avandia is not as dangerous as the public makes it out to be' (Sacramento); 'New studies indicate safety' (Vancouver)."

Despite the near-total absence of valid information about the safety of drugs, these physicians (who of course have to be willing to see reps to be included in the study; a number of candidates were excluded because they never saw reps) rated 57% of the details as "good" or "excellent," and nearly two-thirds of the time stated they were "somewhat" or "very" likely to start prescribing the drug being detailed.

The authors noted that details that were conducted in the way that the vast majority of these apparently were are actually illegal according to the official criteria for the FDA and equivalent agencies in Canada and France, but of course there's virtually no enforcement at the level of the private conversation between rep and doc in the office.

If anyone still thinks that visits from reps to physicians are "not marketing but education," this study seems to put one more nail in that coffin. (Hat tip to Primary Care Medical Abstracts for clueing me in to this article.)